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New treatment option for Hematologic Malignancies
Official title Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06807606
What this study is testing
What is Drugs Cyclophosphamide?
Drugs Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematologic malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 60
You may be able to join if
- Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
- Patient must have relapsed \>100 days since first transplant.
- Diagnosis and Disease Status: a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (\<5% blasts) at the time of transplant, with...
- Prior treatment: a. To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.
- Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16...
See the full eligibility criteria
- Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
- Patient must have relapsed \>100 days since first transplant.
- Diagnosis and Disease Status: a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (\<5% blasts) at the time of transplant, with or without persistent cytogenetic, flow cytometric, or molecular...
- Prior treatment: a. To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.
- Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without...
- Renal and Liver function:
- Calculated creatinine clearance \> 50 ml/min.
- Bilirubin \< 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
- ALT \< 5 x upper limit of normal (ULN).
- Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test.
- Left ventricular ejection fraction (MOD-bp) \> 50%.
- Graft Criteria:
- Two CB units will be selected according to the current MDACC CB unit selection algorithm.
- High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed.
- Unit selection will occur based on HLA-match, total nucleated cell (TNC), and CD34+ cell dose adjusted per patient body weight.
- The bank of origin will also be considered.
- Donor-specific HLA antibodies, if present, will also be taken into consideration.
- Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing.
- Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 107 TNC/ recipient body weight (TNC/ kg).
- Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 105 CD34+ cells/ recipient body weight (CD34+ cells/kg).
- A minimum of one unit will be reserved as a backup graft.
- Each CB unit will be required to be cryopreserved in standard cryovolume. (24- 27 ml/s per unit) and be red blood cell depleted.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.